Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts.
Semin Liver Dis. 2017 Nov;37(4):332-342. doi: 10.1055/s-0037-1608788. Epub 2017 Dec 22.
Alcoholic hepatitis (AH) is an acute and clinically distinct manifestation of alcoholic liver disease. While severe AH causes 30% or higher mortality in 3 months, treatment options are limited and ineffective. Recent advances on the understanding of the pathomechanisms of AH have identified numerous potential targets for new therapeutic interventions. Many of those targets are currently under preclinical testing and/or in human clinical trials for nonalcoholic steatohepatitis. Thus, the field of AH should be ready to launch new efforts and targeted clinical trials for this underserved patient population. There are remaining challenges in designing clinical trials in AH that include definition of the severity of disease, common data elements in clinical trial design, and selection of clinically meaningful endpoints. Future efforts and consensus meetings between regulatory agencies, academic and clinical experts, and industry will be instrumental to advance this emerging and greatly needed field of clinical investigations.
酒精性肝炎（AH）是一种急性且具有临床特征的酒精性肝病。虽然重症 AH 在 3 个月内的死亡率为 30%或更高，但治疗选择有限且效果不佳。对 AH 发病机制的深入了解已确定了许多新的治疗干预的潜在靶点。其中许多靶点目前正在进行临床前测试和/或针对非酒精性脂肪性肝炎的人体临床试验。因此，AH 领域应该准备好为这一未得到充分治疗的患者群体开展新的研究和有针对性的临床试验。在 AH 临床试验的设计中仍然存在一些挑战，包括疾病严重程度的定义、临床试验设计中的常见数据元素以及有临床意义的终点的选择。未来的努力和监管机构、学术和临床专家以及行业之间的共识会议，对于推动这一新兴且急需的临床研究领域将至关重要。
